Exploiting Omics Assays to Investigate Molecular Regulation of Persistent HIV in Individuals with Substance Use Disorder (R61/R33 Clinical Trial Optional) | RFA DA 19 003

Frequently Asked Questions (FAQs)

What is the purpose of NIH funding opportunity RFA-DA-19-003?

This opportunity supports research projects that use modern omics technologies to answer unresolved questions about how persistent HIV is regulated at the molecular level in people with chronic substance use or clinically defined substance use disorder (SUD). The intent is to produce deeper mechanistic insight into HIV persistence specifically in the biological and clinical context shaped by ongoing substance exposure or SUD.

What scientific topics are in scope for this announcement?

The scientific focus is persistent HIV biology, including mechanisms of HIV latency and the formation, maintenance, and behavior of viral reservoirs. Projects must be grounded in the context of ongoing substance use or SUD and should investigate how substance exposure and related biological changes may influence HIV persistence, reactivation, and reservoir dynamics.

What does "persistent HIV" mean in the context of this funding opportunity?

Within this announcement, persistent HIV refers to the biological processes that allow HIV to remain in the body over time, including latency and the presence of viral reservoirs. The program is interested in molecular regulation of these processes, especially as they may be altered by chronic substance exposure or SUD.

Why does this opportunity emphasize substance use or substance use disorder (SUD)?

A defining requirement of the opportunity is that the research be grounded in the context of ongoing substance use or clinically defined SUD. The goal is to understand how substance exposure and associated biological changes can affect HIV persistence, reactivation, and reservoir behavior at the molecular level.

What kinds of technologies or approaches are expected?

The announcement emphasizes modern "omics" and other high-dimensional molecular profiling approaches. Examples listed include genomic, transcriptomic, epigenomic, proteomic, and metabolomic assays, as well as related high-dimensional molecular profiling strategies that can interrogate molecular regulation of HIV persistence in the SUD context.

Does the program support multi-omics or other high-dimensional profiling beyond the examples listed?

The opportunity lists several omics categories as examples and also refers more broadly to "other high-dimensional molecular profiling approaches." Based on the description, approaches beyond the named examples may be responsive if they are omics-style, high-dimensional molecular assays and are clearly used to address mechanistic questions about persistent HIV regulation in people with chronic substance use or SUD.

Is descriptive profiling alone enough to be responsive?

The stated goal goes beyond descriptive profiling. The opportunity seeks actionable understanding of molecular regulation of HIV persistence, latency, and reservoirs in the setting of substance exposure or SUD, with an emphasis on generating deeper mechanistic insight.

What does the R61/R33 phased innovation mechanism mean for applicants?

This award uses an R61/R33 phased innovation mechanism. The R61 phase typically supports early, milestone-driven development and feasibility work. The R33 phase supports expanded, hypothesis-driven research once predefined milestones are met. The structure is intended to enable potentially high-impact projects that need an initial period to establish assays, validate approaches, or demonstrate that the proposed omics strategy can successfully interrogate persistent HIV regulation in the SUD context.

What kinds of activities might occur in the R61 phase?

Based on the description, the R61 phase generally aligns with milestone-driven development and feasibility activities such as establishing or optimizing omics assays, validating approaches, and demonstrating that the omics strategy can effectively interrogate persistent HIV regulation in the SUD context.

What happens in the R33 phase?

The R33 phase is described as supporting expanded, hypothesis-driven research, and it proceeds after predefined milestones for the R61 phase are met.

Are milestones required for transitioning from R61 to R33?

Yes. The phased structure is explicitly described as milestone-driven, with the R33 phase occurring once predefined milestones are met.

Is a clinical trial required?

No. The opportunity is marked "Clinical Trial Optional," meaning applicants may propose studies that do or do not meet the NIH definition of a clinical trial, depending on the research question and design.

What does "Clinical Trial Optional" mean here?

It means the funding opportunity allows either clinical trial studies or non-clinical trial studies. Applicants can choose the study type that best fits their research question and design, as long as it aligns with the scientific goals focused on HIV persistence mechanisms in the context of chronic substance use or SUD.

Which agency is offering this grant opportunity?

The funding opportunity is offered by the National Institutes of Health (NIH).

What is the funding opportunity number (FOA/RFA number)?

The opportunity number is RFA-DA-19-003.

What is the CFDA number associated with this opportunity?

The opportunity is associated with CFDA number 93.279.

What is the maximum award amount (award ceiling) under this announcement?

The listed award ceiling is $450,000, indicating the maximum funding level expected per award under the announcement.

How many awards will NIH make under this opportunity?

The number of expected awards is not specified in the provided information.

When was this opportunity created, and what was the original closing date?

The opportunity was created on 2018-02-15, and the original closing date is listed as 2020-07-17.

What activity area is this grant associated with?

Administratively, this is described as a discretionary grant opportunity in the education and health activity area.

Who is eligible to apply?

Eligibility is broad and includes many types of U.S. and non-U.S. organizations. Examples of domestic eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; Native American tribal governments (federally recognized); Native American tribal organizations (other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses.

Are non-U.S. (foreign) organizations eligible to apply?

Yes. The eligibility language explicitly includes non-domestic (non-U.S.) entities (foreign organizations).

Are for-profit organizations eligible?

Yes. The eligibility list includes for-profit organizations (other than small businesses) and also includes small businesses as eligible applicants.

Are small businesses eligible to apply?

Yes. Small businesses are included in the eligibility list.

Are nonprofits required to have 501(c)(3) status?

No. The eligibility list includes nonprofits with or without 501(c)(3) status (other than institutions of higher education).

Are institutions of higher education eligible?

Yes. Public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible.

Are tribal entities eligible?

Yes. Eligibility includes Native American tribal governments (federally recognized) and Native American tribal organizations (other than federally recognized tribal governments). The announcement also highlights Tribally Controlled Colleges and Universities (TCCUs).

Are minority-serving institutions specifically mentioned as eligible?

Yes. The announcement explicitly highlights Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); and Tribally Controlled Colleges and Universities (TCCUs).

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are explicitly highlighted as eligible applicant categories.

Are federal agencies eligible to apply?

Yes. Eligible federal agencies are explicitly highlighted among eligible applicant categories.

Are U.S. territories or possessions eligible to apply?

Yes. U.S. territories or possessions are explicitly highlighted as eligible applicant categories.

Are regional organizations eligible?

Yes. Regional organizations are explicitly highlighted as eligible applicant categories.

What is the overall expected outcome of funded projects?

The expected outcome is deeper, mechanistic and actionable understanding of molecular regulation of persistent HIV (including latency and reservoir dynamics) in people affected by chronic substance use or SUD. The description notes that this understanding could inform future strategies to control, reduce, or ultimately eliminate persistent HIV reservoirs in people affected by SUD.

What makes a project a good fit for this opportunity based on the description?

Projects are a good fit if they combine HIV persistence science with omics-driven measurement and analysis, and if the work is explicitly grounded in the real-world biological and clinical environment shaped by chronic substance exposure or clinically defined SUD. The program emphasizes mechanistic insight into how substance exposure may influence HIV persistence, reactivation, and reservoir dynamics.